Method for treating urological disorders with a silicone composition



United States Patent M 3 378 440 METHOD FOR TREATII WG UROLOGICAL DIS-ORDERS WITH A SILICONE COMPOSITION Robert L. Rowan and Yetta Rowan, bothof 33 E. th St.,

The present application is a continuation-in-part of our co-pendingapplication Ser. No. 247,286, filed on Dec. 26, 1962, now U.S. PatentNo. 3,239,414.

This invention relates to a method for treating the urological disordersby means of a therapeutic composition and more particularly by means ofa silicone composition used to coat the interior walls of the humanbladder and urethra.

It is a general object of this invention to provide a method forrelieving an inflammation of the human bladder.

It is a more specific object of this invention to provide a method,whereby the walls of the human bladder and urethra are coated with astable and chemically inert liquid and are thereby insulated fromambient internal irritating body fluids such as urine.

It is an other specific object of this invention to provide a novelcoating for the urethra of a patient so as to provide a smooth surfacein the urethra and thereby change the flow characteristics in theurethra of the patient from that favoring turbulent flow to thatfavoring laminar flow.

Still another object of this invention is to provide a new chemical foruse in the treatment of bladder disorders based on a new and differentmechanism of action as Well as a previously unused drug in the humanbladder.

Other objects of this invention will become apparent to those skilled inthe art in the light of the following description.

In accordance with this invention the claimed method and coating used asa therapeutic composition a liquid having as an ingredient anorgano-silicone oxide polymer (also referred to as organo-polysiloxane).These liquids are also popularly called silicones.

It is known that organopolysiloxanes are generally insoluble liquids. Inorder for a liquid to be adapted for internal use such as a coatingagent for the human bladder the liquid must, however, have several otherchemical, physical and physiological properties. For instance, such aliquid should have great thermal and oxidative stability. The liquidshould be chemically inert with the human body fluids. It should alsohave a low volatility.

It has been found that certain organopolysiloxanes and in particulardimethylpolysiloxane, methylphenolpolysiloxane and copolymers ofdimethylpolysiloxane and methylphenylsiloxane liquids, alsomethylpolysiloxane (what is meant here by methylpolysiloxane is apolymer of the type (nxsio in which x may have a value between 1 and 2and where the numerical value of n determines the length of the chainand thereby the viscosity of the liquid, and where R is a CH radical)and diethylpolysiloxane when specially separately prepared and orcombined with the forgoing siloxane polymers have all of theaforementioned desirable properties. The aforementioned liquids aregenerally clear and colorless. They can be sterilized repeatedly withoutsignificantly changing their physical or chemical properties.Furthermore, studies have shown that the aforementioned liquids are,when applied within certain 3,378,440 Patented Apr. 16, 1968 limits tothe human bladder and urethra, completely nontoxic.

The general chemical formula of organopolysiloxanes can be representedas follows:

where R is a CH;, or other organic radial and n=0 to 2000.

The chemical formula of the dimethylpolysiloxane liquids can begeenrally represented as follows:

wherein the length n of the polymer chain determines the viscosity ofthe liquid.

The chemical formula of the methylphenylpolysiloxane liquids can begenerally represented as follows:

wherein the length n of the polymer chain determines the viscosity ofthe liquid; it being understood that the endblocking radicals R can beeither CH or C H The chemical formula of the copolymers ofdimethylpolysiloxane and methylphenylpolysiloxane liquids can egenerally represented as follows:

wherein the length n of the dimethylpolysiloxane polymer chain and n thelength of methylphenylpolysiloxane polymer chain determine the viscosityof the liquid, and where R is a CH or G l-I radical.

The chemical formula of diethylpolysiloxane liquids can be generallyrepresented as follows:

wherein the length n of the polymer chain determines the viscosity ofthe liquid.

An inflammation in the human bladder or urethra is difficul't to treatbecause the bladder and or urethra can not be put to rest as forinstance the immobilizing of an injured extremity of a patient. It. istherefore necessary to treat such an inflammation differently in orderto avoid the constant irritation of the walls of the bladder and/orurethra by the urinary output of the body. Illustrative of such acondition is a patient suffering from idiopathic cystitis. In the lattercase the urine of the patient carries causative material which not onlyirritates but increases the disease process. Similarly if the cause ofthe disease is inherent in the bladder wall, the exposure to the urineacts as an irritant.

While the anatomical arrangement of the urinary tract is normallyconstructed for laminar flow it has also been found that variouspathological phenomena affect the wall of the urinary tract (e.-g.gonorrhea) and transform the characteristics of the wall surface of theurethra so that the latter favors turbulent flow. Burning on urinationis often aggravated by the roughening of the inflamed urethra mucosa.The latter, being sensitive due to pathological phenomena, favorsturbulent flow rather than the normal laminar flow, thereby furtheraggravating the burning sensation.

It has been found that when introducing certain inert :3- and non-toxicorganopolysiloxane liquids into the bladder and urethra the liquideffectively coats the walls of the bladder and urethra and thereby actsas a barrier between the inflamed mucosa walls and the urine.

It has also been found that when introducing certain inert and non-toxicorganopolysiloxane liquids into the roughened and inflamed urethra theliquid forms a smooth coating on the walls of the urethra therebychanging the surface characteristics thereof from those favoringturbulent flow to those favoring laminar flow.

The coating action of the aforementioned organopolysiloxane liquids isso effective because of their relatively low surface tension. Forinstance:

When comparing this with the surface tension of water which is about 72dynes/cm. it becomes apparent why these liquids have such a high surfaceactivity and consequently are such effective coating agents in thebladder and urethra.

It has been found that the afore-listed organopolysiloxane liquids areparticularly effective in relieving the undesirable symptoms of cystitissuch as urinary frequency, bearing down sensations, burning onurination, etc. by protecting the mucosa walls from the irritativeeffects of the urine. This protective coating action is particularlyeffective in treating cases of cystitis and in cases following X-raytherapy to the bladder for cancer. It should be noted, however, that thesilicone liquids are only meant to be used for relief of symptology andno claim is made that the claims set forth hereinafter define a coatingand a method for treating the etiology of any of the aforementionedsymptoms.

Examples of treating patients by the aforedescribed method and with acoating of one or more of the aforedescribed liquids are hereinaftergiven by way of illustration but not by way of limiting the claims setforth below to those examples alone.

Example 1 Sterile disposable equipment is used in order to preclude theneed for washing the silicone liquid from the equipment after its use.The equipment therefore is meant to be discarded after using it onlyonce. The patient is prepared for catheterization by the usual knownsterile technique. A steril disposable urethral catheter with introduceris used to empty the bladder of urine. About ten to twenty cubiccentimeters of dimethylpolysiloxane liquid having a viscosity range from350-1000 centistokes is then instilled into the urethra and bladderforming thereby a coating of dimethylpolysiloxane therein.

Example 2 Sterile equipment is used in order to preclude the need forwashing the silicone liquid from the equipment after its use. A sterileurethral syringe with an introducer neck is used to instilla-bout ten totwenty cubic centimeters of dimethylpolysiloxane liquid, having aviscosity range from 350-1000 centistokes, into the urethra and bladderforming thereby a coating of dimethylpolysiloxane therein.

Example 3 Sterile equipment is used in order to preclude the need forwashing the silicone fluid from the equipment after its use. A sterileurethral syringe with an introducer neck is used to instill about ten totwenty cubic centimeters of methylphenylpolysiloxane liquid having aviscosity range from 350-1000 centistokes, into the urethra and bladderforming thereby a coating of methylphenylpolysiloxane.

Example 4 Sterile equipment is used in order to preclude the need forwashing the silicone liquid from the equipment after its use. A sterileurethral syringe with an introducer neck is used to instill about ten totwenty cubic centimeters of a liquid copolymer consisting ofmethylphenylpolysiloxane and dimethylpolysiloxane, having a viscosityrange from 350-1000 centistokes, into the urethra and bladder formingthereby a coating of a liquid copolymer consisting ofmethylphenylpolysiloxane and dimethylpolysiloxane.

Example 5 Sterile equipment is used in order to preclude the need forwashing the silicone liquid from the equipment after its use. A sterileurethral syringe with an introducer neck is used to instill about ten totwenty cubic centimeters of diethylpolysiloxane liquid, having aviscosity range from 350-1000 centistokes, into the urethra and bladderforming thereby a coating of diethylpolysiloxane therein.

Although a preferred example of the invention has been described, itwill be understood that modifications may be made within the spirit andscope of the appended claim.

We now claim:

1. A method for treating bladder disorders, which comprises the step ofintroducing into the bladder of a patient via the urethra a non-toxicorganopolysiloxane liquid polymer selected from the group ofmethylphenylpolysiloxane, diethylpolysiloxane, methylpolysiloxane andcopolymers of at least two of the aforementioned organopolysiloxanes,said organopolysiloxane liquid polymer having a viscosity within therange of 350-1000 centistokes.

References Cited UNITED STATES PATENTS 3/ 1966 Rowan 167-50

1. A METHOD FOR TREATING BLADDER DISORDERS, WHICH COMPRISES THE STEP OF INTRODUCING INTO THE BLADDER OF A PATIENT VIA THE URETHRA A NON-TOXIC ORGANOPOLYSILOXANE LIQUID POLYMER SELECTED FROM THE GROUP OF METHYLPHENYLPOLYSILOXANE, DIETHYLPOLYSILOXANE, METHYLPOLYSILOXANE AND COPOLYMERS OF AT LEAST TWO OF THE AFOREMENTIONED ORGANOPOLYSILOXANES, SAID ORGANOPOLYSILOXANE LIQUID POLYMER HAVING A VISCOSITY WITHIN THE RANGE OF 350-1000 CENTISTOKES. 